Incomplete reporting of clinically significant acute rejection episodes in the national kidney transplant registry.

Administrative claims data could provide a unique opportunity to identify acute rejection (AR) events using specific antirejection medications and to validate rejected data reported to the Organ Procurement and Transplantation Network. This retrospective cohort study examined differences in registry-reported events and those identified using claims data among adult kidney transplant recipients from 2012 to 2017 using Standard Analysis Files from the US Renal Data System. Rejection rates, survival estimates, and center-level differences were assessed using each approach. Among 45 880 first-time kidney transplant recipients, we identified 3841 AR events within 12 months of transplant reported by centers in the registry; claims data yielded 2945 events. Of all events occurring within 12 months of transplant, 48.5% were reported using registry only, 32.9% were identified using claims only, and 18.6% were identified using both approaches. A 3-year death-censored graft survival probability was 90.0%, 88.4%, and 81.2% (P < .001) for ARs identified using registry only, claims data only, and both approaches, respectively. The large discordance between registry-reported and claims-based events suggests incomplete and potentially inaccurate reporting of events in the Organ Procurement Transplant Network registry. These findings have important implications for analyses that use AR data and underscore the need for improved capture of clinically meaningful events.

Association of Implantation Biopsy Findings in Living Donor Kidneys With Donor and Recipient Outcomes.

RATIONALE & OBJECTIVE: Some living donor kidneys are found to have biopsy evidence of chronic scarring and/or glomerular disease at implantation, but it is unclear if these biopsy findings help predict donor kidney recovery or allograft outcomes. Our objective was to identify the prevalence of chronic histological changes and glomerular disease in donor kidneys, and their association with donor and recipient outcomes. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Single center, living donor kidney transplants from January 2010 to July 2022. EXPOSURE: Chronic histological changes, glomerular disease in donor kidney implantation biopsies. OUTCOME: For donors, single-kidney estimated glomerular filtration rate (eGFR) increase, percent total eGFR loss, ≥40% eGFR decline from predonation baseline, and eGFR<60mL/min/1.73m2 at 6 months after donation; for recipients, death-censored allograft survival. ANALYTICAL APPROACH: Biopsies were classified as having possible glomerular disease by pathologist diagnosis or chronic changes based on the percentage of glomerulosclerosis, interstitial fibrosis/tubular atrophy, and vascular disease. We used logistic regression to identify factors associated with the presence of chronic changes, linear regression to identify the association between chronic changes and single-kidney estimated glomerular filtration rate (eGFR) recovery, and time-to-event analyses to identify the relationship between abnormal biopsy findings and allograft outcomes. RESULTS: Among 1,104 living donor kidneys, 155 (14%) had advanced chronic changes on implantation biopsy, and 12 (1%) had findings suggestive of possible donor glomerular disease. Adjusted logistic regression showed that age (odds ratio [OR], 2.44 per 10 years [95% CI, 1.98-3.01), Hispanic ethnicity (OR, 1.87 [95% CI, 1.15-3.05), and hypertension (OR, 1.92 [95% CI, 1.01-3.64), were associated with higher odds of chronic changes on implantation biopsy. Adjusted linear regression showed no association of advanced chronic changes with single-kidney eGFR increase or relative risk of eGFR<60mL/min/1.73m2. There were no differences in time-to-death-censored allograft failure in unadjusted or adjusted Cox proportional hazards models when comparing kidneys with chronic changes to kidneys without histological abnormalities. LIMITATIONS: Retrospective, absence of measured GFR. CONCLUSIONS: Approximately 1 in 7 living donor kidneys had chronic changes on implantation biopsy, primarily in the form of moderate vascular disease, and 1% had possible donor glomerular disease. Abnormal implantation biopsy findings were not significantly associated with 6-month donor eGFR outcomes or allograft survival. PLAIN-LANGUAGE SUMMARY: Kidney biopsies are the gold standard test to identify the presence or absence of kidney disease. However, kidneys donated by healthy living donors-who are extensively screened for any evidence of kidney disease before donation-occasionally show findings that might be considered "abnormal," including the presence of scarring in the kidney or findings suggestive of a primary kidney disease. We studied the frequency of abnormal kidney biopsy findings among living donors at our center. We found that about 14% of kidneys had chronic abnormalities and 1% had findings suggesting possible glomerular kidney disease, but the presence of abnormal biopsy findings was not associated with worse outcomes for the donors or their recipients.

Disparities in Kidney Transplant Waitlisting Among Young Patients Without Medical Comorbidities.

Importance: Disparities in kidney transplant referral and waitlisting contribute to disparities in kidney disease outcomes. Whether these differences are rooted in population differences in comorbidity burden is unclear. Objective: To examine whether disparities in kidney transplant waitlisting were present among a young, relatively healthy cohort of patients unlikely to have medical contraindications to kidney transplant. Design, Setting, and Participants: This retrospective cohort study used the US Renal Data System Registry to identify patients with end-stage kidney disease who initiated dialysis between January 1, 2005, and December 31, 2019. Patients who were older than 40 years, received a preemptive transplant, were preemptively waitlisted, or had documented medical comorbidities other than hypertension or smoking were excluded, yielding an analytic cohort of 52 902 patients. Data were analyzed between March 1, 2022, and February 1, 2023. Main Outcome(s) and Measure(s): Kidney transplant waitlisting after dialysis initiation. Results: Of 52 902 patients (mean [SD] age, 31 [5] years; 31 132 [59%] male; 3547 [7%] Asian/Pacific Islander, 20 782 [39%] Black/African American, and 28 006 [53%] White) included in the analysis, 15 840 (30%) were waitlisted for a kidney transplant within 1 year of dialysis initiation, 11 122 (21%) were waitlisted between 1 and 5 years after dialysis initiation, and 25 940 (49%) were not waitlisted by 5 years. Patients waitlisted within 1 year of dialysis initiation were more likely to be male, to be White, to be employed full time, and to have had predialysis nephrology care. There were large state-level differences in the proportion of patients waitlisted within 1 year (median, 33%; range, 15%-58%). In competing risk regression, female sex (adjusted subhazard ratio [SHR], 0.92; 95% CI, 0.90-0.94), Hispanic ethnicity (SHR, 0.77; 95% CI, 0.75-0.80), and Black race (SHR, 0.66; 95% CI, 0.64-0.68) were all associated with lower waitlisting after dialysis initiation. Unemployment (SHR, 0.47; 95% CI, 0.45-0.48) and part-time employment (SHR, 0.74; 95% CI, 0.70-0.77) were associated with lower waitlisting compared with full-time employment, and more than 1 year of predialysis nephrology care, compared with none, was associated with greater waitlisting (SHR, 1.51; 95% CI, 1.46-1.56). Conclusions and Relevance: This retrospective cohort study found that fewer than one-third of patients without major medical comorbidities were waitlisted for a kidney transplant within 1 year of dialysis initiation, with sociodemographic disparities in waitlisting even in this cohort of young, relatively healthy patients unlikely to have a medical contraindication to transplantation. Transplant policy changes are needed to increase transparency and address structural barriers to waitlist access.

Discrepant Outcomes between National Kidney Transplant Data Registries in the United States.

SIGNIFICANCE STATEMENT: Effects of reduced access to external data by transplant registries to improve accuracy and completeness of the collected data are compounded by different data management processes at three US organizations that maintain kidney transplant-related datasets. This analysis suggests that the datasets have large differences in reported outcomes that vary across different subsets of patients. These differences, along with recent disclosure of previously missing outcomes data, raise important questions about completeness of the outcome measures. Differences in recorded deaths seem to be increasing in recent years, reflecting the adverse effects of restricted access to external data sources. Although these registries are invaluable sources for the transplant community, discrepancies and incomplete reporting risk undermining their value for future analyses, particularly when used for developing national transplant policy or regulatory measures. BACKGROUND: Central to a transplant registry's quality are accuracy and completeness of the clinical information being captured, especially for important outcomes, such as graft failure or death. Effects of more limited access to external sources of death data for transplant registries are compounded by different data management processes at the United Network for Organ Sharing (UNOS), the Scientific Registry of Transplant Recipients (SRTR), and the United States Renal Data System (USRDS). METHODS: This cross-sectional registry study examined differences in reported deaths among kidney transplant candidates and recipients of kidneys from deceased and living donors in 2000 through 2019 in three transplant datasets on the basis of data current as of 2020. We assessed annual death rates and survival estimates to visualize trends in reported deaths between sources. RESULTS: The UNOS dataset included 77,605 deaths among 315,346 recipients and 61,249 deaths among 275,000 nonpreemptively waitlisted candidates who were never transplanted. The SRTR dataset included 87,149 deaths among 315,152 recipients and 60,042 deaths among 259,584 waitlisted candidates. The USRDS dataset included 89,515 deaths among 311,955 candidates and 63,577 deaths among 238,167 waitlisted candidates. Annual death rates among the prevalent transplant population show accumulating differences across datasets-2.31%, 4.00%, and 4.03% by 2019 from UNOS, SRTR, and USRDS, respectively. Long-term survival outcomes were similar among nonpreemptively waitlisted candidates but showed more than 10% discordance between USRDS and UNOS among transplanted patients. CONCLUSIONS: Large differences in reported patient outcomes across datasets seem to be increasing, raising questions about their completeness. Understanding the differences between these datasets is essential for accurate, reliable interpretation of analyses that use these data for policy development, regulatory oversight, and research. PODCAST: This article contains a podcast at https://dts.podtrac.com/redirect.mp3/www.asn-online.org/media/podcast/JASN/2023_10_24_JASN0000000000000194.mp3.

Characterization of Transplant Center Decisions to Allocate Kidneys to Candidates With Lower Waiting List Priority.

Importance: Allocation of deceased donor kidneys is meant to follow a ranked match-run list of eligible candidates, but transplant centers with a 1-to-1 relationship with their local organ procurement organization have full discretion to decline offers for higher-priority candidates and accept them for lower-ranked candidates at their center. Objective: To describe the practice and frequency of transplant centers placing deceased donor kidneys with candidates who are not the highest rank at their center according to the allocation algorithm. Design, Setting, and Participants: This retrospective cohort study used 2015 to 2019 organ offer data from US transplant centers with a 1-to-1 relationship with their local organ procurement organization, following candidates for transplant events from January 2015 to December 2019. Participants were deceased kidney donors with a single match-run and at least 1 kidney transplanted locally and adult, first-time, kidney-only transplant candidates receiving at least 1 offer for a locally transplanted deceased donor kidney. Data were analyzed from March 1, 2022 to March 28, 2023. Exposure: Demographic and clinical characteristics of donors and recipients. Main Outcomes and Measures: The outcome of interest was kidney transplantation into the highest-priority candidate (defined as transplanted after zero declines for local candidates in the match-run) vs a lower-ranked candidate. Results: This study assessed 26 579 organ offers from 3136 donors (median [IQR] age, 38 [25-51] years; 2903 [62%] men) to 4668 recipients. Transplant centers skipped their highest-ranked candidate to place kidneys further down the match-run for 3169 kidneys (68%). These kidneys went to a median (IQR) of the fourth- (third- to eighth-) ranked candidate. Higher kidney donor profile index (KDPI; higher score indicates lower quality) kidneys were less likely to go to the highest-ranked candidate, with 24% of kidneys with KDPI of at least 85% going to the top-ranked candidate vs 44% of KDPI 0% to 20% kidneys. When comparing estimated posttransplant survival (EPTS) scores between the skipped candidates and the ultimate recipients, kidneys were placed with recipients with both better and worse EPTS than the skipped candidates, across all KDPI risk groups. Conclusions and Relevance: In this cohort study of local kidney allocation at isolated transplant centers, we found that centers frequently skipped their highest-priority candidates to place kidneys further down the allocation prioritization list, often citing organ quality concerns but placing kidneys with recipients with both better and worse EPTS with nearly equal frequency. This occurred with limited transparency and highlights the opportunity to improve the matching and offer algorithm to improve allocation efficiency.

Contribution of Estimates of Glomerular Filtration to the Extensive Disparities in Preemptive Listing for Kidney Transplant.

Introduction: The use of race coefficients in equations for estimated glomerular filtration rate (eGFR) may have contributed to racial disparities in access to preemptive (without dialysis exposure) kidney transplantation (Ktx). Methods: In this retrospective national cohort study of incident kidney transplant candidates in the United States from 2001 to 2019, we describe temporal trends and racial disparities in preemptive listing and the distribution of eGFR at listing, using eGFR as reported and after removing the race coefficient for Black candidates. Results: Among 511,686 candidates, preemptive listing increased over time, from 18% in 2001 to 33% in 2019. Non-Black candidates were listed preemptively nearly twice as frequently as Black candidates in 2019 (38% vs. 21% preemptive) and at higher eGFR values (median 15.6 vs. 15.0 ml/min per 1.73 m2). After adjusting for candidate characteristics, including listing eGFR without the race coefficient, preemptive Black candidates still had significantly lower odds of preemptive deceased donor (DD) kidney transplantation compared to non-Black candidates (odds ratio 0.87, 95% confidence interval: 0.78-0.98). Conclusions: Over the last 2 decades, Black patients were consistently less likely to be listed preemptively and were listed at lower eGFR values. Adjusting for listing eGFR with the race coefficient computationally removed did not eliminate the racial disparity, suggesting that additional efforts are needed to achieve equity in preemptive transplantation beyond adopting race-free eGFR equations.

Deceased donor kidneys from higher distressed communities are significantly less likely to be utilized for transplantation.

The proportion of kidneys procured for transplantation but not utilized exceeds 20% in the United States. Factors associated with nonutilization are complex, and further understanding of novel causes are critically important. We used the national Scientific Registry of Transplant Recipients data (2010-2022) to evaluate associations of Distressed Community Index (DCI) of deceased donor residence and likelihood of kidney nonutilization (n = 209 413). Deceased donors from higher distressed communities were younger, had an increased history of hypertension and diabetes, were CDC high-risk, and had higher terminal creatinine and donation after brain death. Mechanisms and circumstances of death varied significantly by DCI. The proportion of kidney nonutilization was 19.9%, which increased by DCI quintile (Q1 = 18.1% to Q5 = 21.6%). The adjusted odds ratio of nonutilization from the highest quintile DCI communities was 1.22 (95% CI = 1.16-1.28; reference = lowest DCI), which persisted stratified by donor race. Donors from highly distressed communities were highly variable by the donor service area (range: 1%-51%; median = 21%). There was no increased risk for delayed graft function or death-censored graft loss by donor DCI but modest increased adjusted hazard for overall graft loss (high DCI = 1.05; 95% CI = 1.01-1.10; reference = lowest DCI). Results indicate that donor residential distress is associated with significantly higher rates of donor kidney nonutilization with notable regional variation and minimal impact on recipient outcomes.

Effects of Delayed Graft Function on Transplant Outcomes: A Meta-analysis.

Delayed graft function (DGF) is a frequent complication of kidney transplantation, but its impact on long- and short-term transplant outcomes is unclear. We conducted a systematic literature search for studies published from 2007 to 2020 investigating the association between DGF and posttransplant outcomes. Forest plots stratified between center studies and registry studies were created with pooled odds ratios. Posttransplant outcomes including graft failure, acute rejection, patient mortality, and kidney function were analyzed. Of the 3422 articles reviewed, 38 papers were included in this meta-analysis. In single-center studies, patients who experienced DGF had increased graft failure (odds ratio [OR] 3.38; 95% confidence interval [CI], 1.85-6.17; P < 0.01), acute allograft rejection (OR 1.84; 95% CI, 1.30-2.61; P < 0.01), and mortality (OR 2.32; 95% CI, 1.53-3.50; P < 0.01) at 1-y posttransplant. Registry studies showed increased graft failure (OR 3.66; 95% CI, 3.04-4.40; P < 0.01) and acute rejection (OR 3.24; 95% CI, 1.88-5.59; P < 0.01) but not mortality (OR 2.27; 95% CI, 0.97-5.34; P = 0.06) at 1-y posttransplant. DGF was associated with increased odds of graft failure, acute rejection, and mortality. These results in this meta-analysis could help inform the selection process, treatment, and monitoring of transplanted kidneys at high risk of DGF.

Retrospective analysis of the impact of severe obesity on kidney transplant outcomes.

BACKGROUND: The prevalence of obesity among kidney transplant recipients is rising. We sought to determine the association between recipient body mass index (BMI) and post-transplant complications. METHODS: Single-center, retrospective cohort study of all adult kidney transplant recipients from 2004 to 2020. Recipients were stratified into four BMI categories: normal-weight (BMI 18.5-24.9 kg/m2, n = 1020), overweight (BMI 25-29.9 kg/m2, n = 1002), moderately obese (BMI 30-34.9 kg/m2, n = 510) and severely-to-morbidly obese (BMI ≥35 kg/m2, n = 274). Logistic regression was used to estimate the association between BMI category and surgical site infections (SSIs). RESULTS: Recipients with BMI ≥35 kg/m2 had significantly higher rates of SSIs (P < .0001) compared with recipients in all other categories. On multivariable analysis, recipients with BMI ≥35 kg/m2 had increased odds of SSIs compared with normal-weight recipients [odds ratio (OR) 3.34, 95% confidence interval (CI) 1.55-7.22, P = .022). On multivariable and Kaplan-Meier analyses, no BMI groups demonstrated increased odds for death-censored graft failure. CONCLUSION: Severe obesity in kidney transplant recipients is associated with increased SSIs, but not kidney allograft failure.

Influence of organ quality on the observed association between deceased donor kidney procurement biopsy findings and graft survival.

Deceased donor kidney procurement biopsies findings are the most common reason for kidney discard. Retrospective studies have found inconsistent associations with post-transplant outcomes but may have been limited by selection bias because kidneys with advanced nephrosclerosis from high-risk donors are typically discarded. We conducted a retrospective cohort study of kidneys transplanted in the United States from 2015 to 2019 with complete biopsy data available, defining "suboptimal histology" as glomerulosclerosis ≥11%, IFTA ≥mild, and/or vascular disease ≥mild. We used time-to-event analyses to determine the association between suboptimal histology and death-censored graft failure after stratification by kidney donor profile index (KDPI) (≤35%, 36%-84%, ≥85%) and final creatinine (<1 mg/dl, 1-2 mg/dl, >2 mg/dl). Among 30 469 kidneys included, 36% had suboptimal histology. In adjusted analyses, suboptimal histology was associated with death-censored graft failure among kidneys with KDPI 36-84% (HR 1.22, 95% CI 1.09-1.36), but not KDPI≤35% (HR 1.24, 0.94-1.64) or ≥ 85% (HR 0.99, 0.81-1.22). Similarly, suboptimal histology was associated with death-censored graft failure among kidneys from donors with creatinine 1-2 mg/dl (HR 1.39, 95% CI 1.20-1.60) but not <1 mg/dl (HR 1.07, 0.93-1.23) or >2 mg/dl (HR 0.95, 0.75-1.20). The association of procurement histology with graft longevity among intermediate-quality kidneys that were likely to be both biopsied and transplanted suggests biopsies provide independent organ quality assessments.